Abstract: A pneumostoma management system which includes a pneumostoma management device and a cover. The pneumostoma management device maintains the patency of a pneumostoma while controlling the flow of material through the pneumostoma. The pneumostoma management device includes a hydrophobic filter and/or a one-way filter. The cover serves to protect the pneumostoma management device and/or provide a cosmetic skin to make the pneumostoma management device more acceptable to the patient and thereby encourage patient compliance with a pneumostoma treatment regimen.

Abstract: A method for maintaining the patency of a pneumostoma while controlling the flow of material through the pneumostoma. A pneumostoma management system includes a two-part pneumostoma management device and associated insertion and removal tools. The pneumostoma management device includes a pneumostoma vent and a chest mount for positioning and securing the vent into a pneumostoma. To use the system, the chest is first cleaned and the chest mount secured to the chest adjacent the pneumostoma. The pneumostoma vent is then inserted into the pneumostoma through an aperture in the chest mount until it is engaged and secured by a coupling of the chest mount. The pneumostoma vent may be replaced periodically such as daily. The chest mount may be changed less frequently such as weekly.

Abstract: A pneumostoma management system for maintaining the patency of a pneumostoma while controlling the flow of material through the pneumostoma. The pneumostoma management system includes a two-part pneumostoma management device and associated insertion and removal tools. The pneumostoma management device includes a pneumostoma vent and a chest mount for positioning and securing the vent into a pneumostoma. The pneumostoma vent includes a hydrophobic filter and/or a one-way valve.

Abstract: A flexible pneumostoma management device maintains the patency of a pneumostoma while controlling the flow of material through the pneumostoma. The pneumostoma management device includes a pneumostoma vent having a tube which enters the pneumostoma to allow gases to escape the lung, a flange and a filter/valve to control flow of materials through the tube. The flange is a thin flexible patch which conforms and attaches to the chest of the patient. The flange secures the tube in position in the pneumostoma. The device has features to control secretions from the pneumostoma. The secretion management features include, ridges, pores, absorbent materials, and combinations thereof.

Abstract: Methods and devices are provided for reconfiguring a tissue within a hollow body organ using an entirely endoscopic approach in order to effectively reduce flow of fluid contents into a second hollow body organ in fluid communication with the first.

Abstract: The present invention relates to devices and methods for the endoscopic treatment of hollow organs. The invention provides improved devices and methods for apposing and fixating multiple regions of the outer surface of a hollow organ. The invention is particularly useful for procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated, for example procedures to treat gastroesophageal reflux disease (GERD) or procedures to treat obesity.

Abstract: An apparatus includes an elongated member configured for transoral placement into a stomach, and a distal end effector including first and second members configured to engage stomach tissue, e.g., tissue beyond the esophageal junction. The first and second members are movable relatively toward one another generally in a first plane, and the distal end effector is movable relative to the elongated member in a second plane generally transverse to the first plane. A third member of the distal end effector is configured to engage stomach tissue. The third member is movable in a distal direction relative to the first and second members. A tissue securement member of the apparatus is coupled to at least one of the first and second members for securing together tissue engaged thereby.

Abstract: A method includes advancing an apparatus having an elongated member transorally into the stomach. The apparatus includes a distal end effector having first and second members configured to engage tissue. The first and second members are movable relatively toward one another generally in a first plane. The method includes moving the distal end effector relative to the elongated member in the first plane such that the distal end effector is retroflexed out of alignment with the elongated member to position the first and second members for engagement with the tissue. At least one of the first and second members carries a fixation device for fixing engaged portions of tissue together.

Abstract: A medical instrument for engaging tissue includes a flexible shaft, a tissue piercing coil at a distal portion of the shaft, and a tissue stabilizer positioned over the shaft and biased in a distal direction such that as the tissue piercing coil enters tissue, the tissue stabilizer is urged against a surface of the tissue. A medical instrument for reconfiguring tissue includes a flexible shaft defining a lumen housing actuating controls, and a distal actuating assembly with a sealing portion configured to substantially seal the shaft lumen from contact with bodily fluids. A cartridge assembly includes first and second members configured for releasable attachment to a medical instrument, and a holder configured to receive the first and second members and to be released from the first and second members upon action of the first and second members attaching to the medical instrument.

Abstract: A medical instrument for engaging tissue includes a flexible shaft, a tissue piercing coil at a distal portion of the shaft, and a tissue stabilizer positioned over the shaft and biased in a distal direction such that as the tissue piercing coil enters tissue, the tissue stabilizer is urged against a surface of the tissue. A medical instrument for reconfiguring tissue includes a flexible shaft defining a lumen housing actuating controls, and a distal actuating assembly with a sealing portion configured to substantially seal the shaft lumen from contact with bodily fluids. A cartridge assembly includes first and second members configured for releasable attachment to a medical instrument, and a holder configured to receive the first and second members and to be released from the first and second members upon action of the first and second members attaching to the medical instrument.

Abstract: A medical instrument for engaging tissue includes a flexible shaft, a tissue piercing coil at a distal portion of the shaft, and a tissue stabilizer positioned over the shaft and biased in a distal direction such that as the tissue piercing coil enters tissue, the tissue stabilizer is urged against a surface of the tissue. A medical instrument for reconfiguring tissue includes a flexible shaft defining a lumen housing actuating controls, and a distal actuating assembly with a sealing portion configured to substantially seal the shaft lumen from contact with bodily fluids. A cartridge assembly includes first and second members configured for releasable attachment to a medical instrument, and a holder configured to receive the first and second members and to be released from the first and second members upon action of the first and second members attaching to the medical instrument.

Abstract: A medical instrument for engaging tissue includes a flexible shaft, a tissue piercing coil at a distal portion of the shaft, and a tissue stabilizer positioned over the shaft and biased in a distal direction such that as the tissue piercing coil enters tissue, the tissue stabilizer is urged against a surface of the tissue. A medical instrument for reconfiguring tissue includes a flexible shaft defining a lumen housing actuating controls, and a distal actuating assembly with a sealing portion configured to substantially seal the shaft lumen from contact with bodily fluids. A cartridge assembly includes first and second members configured for releasable attachment to a medical instrument, and a holder configured to receive the first and second members and to be released from the first and second members upon action of the first and second members attaching to the medical instrument.

Abstract: A medical instrument for engaging tissue includes a flexible shaft, a tissue piercing coil at a distal portion of the shaft, and a tissue stabilizer positioned over the shaft and biased in a distal direction such that as the tissue piercing coil enters tissue, the tissue stabilizer is urged against a surface of the tissue. A medical instrument for reconfiguring tissue includes a flexible shaft defining a lumen housing actuating controls, and a distal actuating assembly with a sealing portion configured to substantially seal the shaft lumen from contact with bodily fluids. A cartridge assembly includes first and second members configured for releasable attachment to a medical instrument, and a holder configured to receive the first and second members and to be released from the first and second members upon action of the first and second members attaching to the medical instrument.

Abstract: Methods and devices are provided for reconfiguring a tissue within a hollow body organ using an entirely endoscopic approach in order to effectively reduce flow of fluid contents into a second hollow body organ in fluid communication with the first.

Abstract: Methods and devices are provided for reconfiguring a tissue within a hollow body organ using an entirely endoscopic approach in order to effectively reduce flow of fluid contents into a second hollow body organ in fluid communication with the first.

Abstract: A tissue fixation device may include a suture, a first securing element connected to a first portion of the suture, and a second securing element connected to a second portion of the suture. The first and second securing elements are each rotatable from a first position during deployment of the tissue fixation device that is suitable for each securing element to pass through a respective hole formed in tissue to a second position when the tissue fixation device is deployed that inhibits each securing element from passing through the respective hole formed in the tissue. An exemplary method of fixing tissue may include creating two holes in the tissue and deploying a tissue fixation device having a suture connecting two securing elements by advancing each securing element through a respective hole in the tissue and causing each securing element to rotate to a position that inhibits the securing element from passing through the respective hole.

Abstract: An instrument for reconfiguring stomach tissue includes a sealing member that seals a section of a tissue manipulator from contact with bodily fluids. The tissue manipulator includes a first portion that is configured for releasable coupling to an actuating member and a second portion configured to receive an implant to be deployed within the patient. The tissue manipulator also includes a rectangular member and a cavity for receiving a coupler of the actuating member. The tissue manipulator has a first member with tissue penetrating elements and a second member with engaging elements configured to deflect the tissue penetrating elements upon relative movement of the first and second members. The actuating member includes a tissue penetrating element support positioned to limit bending of the tissue manipulator. The instrument includes an actuating mechanism that is configured to move at least one of the first and second members of the tissue manipulator.

Abstract: Methods and devices are provided for reconfiguring a tissue within a hollow body organ using an entirely endoscopic approach in order to effectively reduce flow of fluid contents into a second hollow body organ in fluid communication with the first.

Abstract: A method includes advancing an apparatus having an elongated member transorally into the stomach. The apparatus includes a distal end effector having first and second members configured to engage tissue. The first and second members are movable relatively toward one another generally in a first plane. The method includes moving the distal end effector relative to the elongated member in the first plane such that the distal end effector is retroflexed out of alignment with the elongated member to position the first and second members for engagement with the tissue. At least one of the first and second members carries a fixation device for fixing engaged portions of tissue together.

Abstract: An apparatus includes an elongated member configured for transoral placement into a stomach, and a distal end effector including first and second members configured to engage stomach tissue, e.g., tissue beyond the esophageal junction. The first and second members are movable relatively toward one another generally in a first plane, and the distal end effector is movable relative to the elongated member in a second plane generally transverse to the first plane. A third member of the distal end effector is configured to engage stomach tissue. The third member is movable in a distal direction relative to the first and second members. A tissue securement member of the apparatus is coupled to at least one of the first and second members for securing together tissue engaged thereby.